Proceed with the instructions and follow it to register and pay for the course.
Take this course: Follow the “Take This Course" Button by clicking at the Top Right Hand Side of the Page. This course aims to provide participants with the knowledge and skills necessary to carry out audits of management systems against ISO 13485:2016, in. This means you have unconditionally no risk when registering to this Course.Īsk Questions & Report Complaints: Discussion forum on the right side of this course can be used to discuss specific queries and report problems you are facing about the content of the course. One Month Money Back Guarantee: Don't forget One Month 100% Money Back Guarantee without inquiry. If you feel that you lack the knowledge you can take ISO 13485 courses from Udemy or the instructor to guide you on gaining ISO 13485 knowledge. Good news: We will be adding more content for example case studies to practice tests in the future. Note: ISO 13485 standard is a copyright document of ISO. Or you can prove your knowledge and expertise by successfully completing this exam.īoth ways, you are in a win-win situation. If you think you are an expert in ISO 13485 after taking courses on the subject and working with ISO 13485. ISO 13485:2016 interpretation in companiesīe Familiar with ISO 13485:2016 knowledge which you hold. The specific differences between ISO 13485:2016 and the older versions The publication of new ISO 13485 standard You will be assessed when you take this online exam in following areas (Course Objectives): The certificates are issued at the end of a month.
It is a manual process, in which learners our requested to submit evidence of qualification, and apply for the certificate. But the great news here is, we have empowered our paid students to have a certificate, once they qualify by 80% in the exams. Passing Certification Awarded By InstructorĬertification: Udemy does not provide certification for exams, they only do in the case of Video Courses. This "knowledge validation exam" helps you to check and validate your knowledge on ISO 13485:2016 standard and its fundamental concepts like importance of regulatory compliance, medical device file, product recall and advisory notices etc.
Similarly if you are a quality professional and ISO 13485 beginner, or expert you also have to check your expertise in Quality Management System. Organizations have to check themselves whether their operations are done according to plan phase or not.
The standard is based on regulatory frameworks like FDA 21 CFR Part 820 and ISO 9001:2008. Participants of the training will learn from highly experienced instructors with decades of experience in medical device quality management systems.ISO 13485:2016 standard is made on the quality philosophy of Plan, do, check and Act Cycle. Upon completion, the participants will be capable to audit ISO 13485:2016 and jurisdiction requirements in the countries participating in the MDSAP program. Quality directors, regulatory managers, and professionals responsible for managing internal, corporate, supply chain or certification responsibilities may also benefit from this unique program. The course is designed for medical device professionals with the responsibility for conducting or implementing internal audits, supplier audits, or corporate audits. The course provides extensive practical training and hands-on exercises, which will help prepare medical device auditors to identify critical nonconformities and meet international regulatory requirements. Auditing standards include MDSAP requirements, ISO 19011, and ISO 17021 (MDSAP auditors need to follow ISO 17021).Ĭonsidering the ISO 13485:2016 management system requirements and various regulatory authorities compliance requirements around the world and the global supply chains involved, a comprehensive program like OMNEX’s MDSAP Lead Auditor Training’ is incredibly valuable. OMNEX’s Lead Auditor Training course will teach students to plan, conduct, report, and follow up on QMS audits in accordance with ISO 13485:2016 and MDSAP. Students participating in this course will gain knowledge and skills to conduct audits of ISO13485: 2016 management system requirements in accordance with the new MDSAP Audit Model.
Medical device auditing requires technical knowledge as well as a deep understanding of international medical device regulations. The internationally recognized PECB Lead Auditor certificate proves that you have the capabilities and competences to audit organizations based on best practices.
The five-day training is focused on international MDSAP and ISO 13485 compliant medical device requirements and auditing methods. After completing this training course, you can sit for the exam and, if you successfully pass the exam, you can apply for the 'PECB Certified ISO 27701 Lead Auditor' credential. OMNEX is now offering QMS Lead Auditor training based on both ISO 13485:2016 and the International Medical Device Single Audit Program (MDSAP). Register for courses 30 days in advance and get 5% off this price Note:Pricing is dependent on location and may vary.